BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 8962195 · Received September 4, 2019

    Report

    Report Number
    2027111-2019-00578
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Report Date
    October 4, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K072674
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT'S EXPERIENCE COULD NOT BE CONFIRMED OR REPLICATED. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. EMAIL HAS IMPLIED A PREVIOUS EVENT (TWO ISSUES) WHERE THE KII THREADED BLADED TROCAR HAS NOT FUNCTIONED CORRECTLY FOR UNKNOWN REASONS AND IT IS ALSO UNKNOWN WHEN THIS HAPPENED. THESE EVENT ARE RECORDED IN APPLIED MEDICAL REFERENCE NUMBERS (B)(4) (REPORT # 2027111-2019-00577) AND (B)(4) (REPORT # 2027111-2019-00578). BELOW EMAIL RECEIVED ON 21ST AUGUST 2019 FROM USER FACILITY REP: "NOW I AM AFRAID THAN MR [NAME] HAS HAD TWO ISSUES WITH THE TROCARS. THEY HAVE NOT RETRACTED. ONE CAUSED SLIGHT BOWEL DAMAGE AND RESULTED IN HIM RAISING IT AS A SAFETY ISSUE. I APPRECIATE THAT MR [NAME] REFUSED TRAINING, REFUSED TO HAVE YOU IN HIS THEATRE AND INDEED, WAS NOT PLEASANT WENT YOU TRIED TO SPEAK TO HIM." PATIENT STATUS: NO INJURY OCCURED.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WILL NOT BE RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE EVENT DATE IS UNKNOWN. EMAIL HAS IMPLIED A PREVIOUS EVENT (TWO ISSUES) WHERE THE KII THREADED BLADED TROCAR HAS NOT FUNCTIONED CORRECTLY FOR UNKNOWN REASONS AND IT IS ALSO UNKNOWN WHEN THIS HAPPENED. THESE EVENT ARE RECORDED IN APPLIED MEDICAL REFERENCE NUMBERS 2019-002112 AND 2019-002113. BELOW EMAIL RECEIVED ON (B)(6) 2019 FROM USER FACILITY REP: "NOW I AM AFRAID THAN MR [NAME] HAS HAD TWO ISSUES WITH THE TROCARS. THEY HAVE NOT RETRACTED. ONE CAUSED SLIGHT BOWEL DAMAGE AND RESULTED IN HIM RAISING IT AS A SAFETY ISSUE. I APPRECIATE THAT MR [NAME] REFUSED TRAINING, REFUSED TO HAVE YOU IN HIS THEATRE AND INDEED, WAS NOT PLEASANT WENT YOU TRIED TO SPEAK TO HIM." PATIENT STATUS: NO INJURY OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755305 UNK LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTB03 OR CTB73 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1